Resolving Unsolved Rare Diseases : Functional Tests and New Diagnosis Strategy to Study Genetic Variants From High-throughput Sequencing (RID)

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Rares diseases are a heterogeneous group of conditions which need important tools for diagnosis. The use of high-throughput sequencing is able to diagnose half of the patients. For the other part it is impossible to conclude due to the presence of variants of unknown significance (VOUS). Functional analysis are needed to bring strong argument to reclassify variants as pathogenic or benign. The main objective is to evaluate the diagnosis yield of this strategy.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Minor and adult patient.

• Registered for the social security system.

• Informed consent signed by patient or parent of a minor patient.

• Patient affected by one of the rare diseases studied (albinism, congenital heart defect, cystic fibrosis, neurodevelopmental disease)

• Patient bearing variants of unknown significance (VOUS)

Locations
Other Locations
France
Hopital Pellegrin
RECRUITING
Bordeaux
Contact Information
Primary
Vincent MICHAUD
vincent.michaud@chu-bordeaux.fr
+335 57 82 01 93
Backup
Ndeye-Fatou NGOM
ndeye-fatou.ngom@chu-bordeaux.fr
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2025-02
Participants
Target number of participants: 50
Treatments
Other: Ex-vivo and In-vitro approach
Ex-vivo approach concerning 25 patients with blood sample in PAXgene tubes or skin biopsy and RNA-Seq analysis.~In-vitro approach concerning 25 patients without specific samples needed for analysis in minigene or luciferase assay
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov